MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use user manual states that perforation of vessels, pain and hypotension are potential adverse events that may occur and/or require intervention with use of the system.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a severely calcified, 85% stenosed lesion in the left anterior descending (lad) artery via femoral approach.The vessel was 2.5-3.0 mm in diameter.Three low-speed treatments were performed in the proximal lad with no issues.The oad was then advanced to the mid lad.The first treatment was successful but during the second treatment the physician thought the oad stalled when the torque guard turned on.The oad was retracted, glideassist was turned on, and the oad restarted.Angiographic imaging was performed which revealed contrast staining in the lad.The patient experienced mild chest pain and hypotension.A bolus of neo-synephrine was administered and a non-csi/non-abbott balloon was quickly advanced to tamponade the perforation.In the opinion of the physician the perforation was contained within the adventitia and could have been a ruptured hematoma due to non-pulsatile blood flow to the perforation.The physician believes that he should not have spun the second lesion because of the size and tortuosity of the vessel with the viperwire advance coronary guide wire.After balloon removal, covered stent placement followed.The patient stabilized very quickly.The procedure was completed with no further complications.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul 55112
• MDR Report Key: 19033912
• MDR Text Key: 339264943
• Report Number: 3004742232-2024-00148
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Lot Number: 504326-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female